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[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.49]

[Page 198]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 20 PUBLIC INFORMATION--Table of Contents
 
                      Subpart C Procedures and Fees
 
Sec.  20.49  Denial of a request for records.

    (a) A denial of a request for records, in whole or in part, shall be 
signed by the Assistant Commissioner for Public Affairs (or delegatee).
    (b) The name and title or position of each person who participated 
in the denial of a request for records shall be set forth in the letter 
denying the request. This requirement may be met by attaching a list of 
such individuals to the letter.
    (c) A letter denying a request for records, in whole or in part, 
shall state the reasons for the denial and shall state that an appeal 
may be made to the Deputy Assistant Secretary for Public Affairs 
(Media), Department of Health and Human Services. The agency will also 
make a reasonable effort to include in the letter an estimate of the 
volume of the records denied, unless providing such an estimate would 
harm an interest protected by an exemption under the Freedom of 
Information Act. This estimate will ordinarily be provided in terms of 
the approximate number of pages or some other reasonable measure. This 
estimate will not be provided if the volume of records denied is 
otherwise indicated through deletions on records disclosed in part.
    (d) Minor deletions of nondisclosable data and information from 
disclosable records shall not be deemed to be a denial of a request for 
records.

[42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981; 55 
FR 1405, Jan. 16, 1990. Redesignated and amended at 68 FR 25286, 25287, 
May 12, 2003]




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